A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.
• Female at least 22 years old
• Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
• Provocative pad weight of greater than 11.0 grams
• Candidate for surgical intervention
• Negative urinalysis
• Normal cystourethroscopy
• Failed at least 6 months of previous treatment(s) for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc). Note: patients may have failed prior anti-incontinence procedures for SUI (e.g., suspension, sling, or urethral bulking agent)
• Willing and able to sign informed consent and comply with trial follow-up requirements